News & Views: Flu vaccine supply, Rare Disease Day, Childhood Cancer Advocacy Forum, Heart Devices, Physiologically Based Pharmacokinetic (PBPK) Modeling
Ensuring Supply of Influenza Vaccine
Starts well before the current flu season ends – a year-round initiative
- Vaccine composition changes every year as flu viruses are constantly evolving
- Collaboration of FDA, WHO, CDC to evaluate global circulating strains and disease trends
- FDA advisory committee recommend 3-4 strains to include in trivalent and quadrivalent influenza vaccines
- Manufacturers begin manufacturing process to include the newly selected flu strains and seek FDA approval for lot release – quality control tests, including testing for sterility
Observation of Rare Disease Day
Created to raise awareness about the 7,000 known rare diseases with theme of Bridging Health and Social Care
- public meeting – “Patient Perspectives of the Impact of Rare Diseases: Bridging the Commonalities” to obtain perspectives on impacts on daily life
- latest FDA Voices post, on progress made and continued patient engagement efforts
- video on Patients Matter: Giving Patients A Seat at the Table– ro share their unique perspectives, experiences, and concerns
Oncology Center of Excellence Childhood Cancer Advocacy Forum
Topics for Discussion:
- FDA’s External Engagement and Patient Advocacy: A Dialogue to Better Inform FDA of Patient Needs and Priorities
- Avoiding Pitfalls in Drug Development
- Approved Cancer Drugs in Children
- BPCA/WR Study Results
- Expanded Access to Investigational Drugs
- FDARA Implementation
- Pediatric PROs: Are they feasible?
Register here for in-person or online attendance
Heart Devices regulated by FDA
- Automated external defibrillators (AEDs): Portable and automatic, to restore normal heart rhythm
- Cardiac ablation catheters: Long, thin flexible tubes. to treat abnormally rapid heartbeats
- Cardiovascular angioplasty devices: Long, thin, flexible tubes threaded into heart vessel to open narrowed or blocked areas
- Cardiac pacemakers: Small, battery-powered, implanted permanently, monitor heart’s electrical impulses. deliver electrical stimulation if bradycardia
- Implantable cardioverter defibrillators (ICDs): Monitor heart rhythms and deliver shocks if dangerous tachycardia
- Prosthetic (artificial) heart valves: Replacing diseased or dysfunctional heart valves,
- Stents: Small, lattice-shaped, metal tubes, some with drugs, to improve blood flow
- Ventricular assist devices (VADs): Mechanical pumps for short-term or long term use
Warning signs and symptoms of a heart attack
Supporting Drug Development Through Physiologically Based Pharmacokinetic (PBPK) Modeling
PBPK Models to Mechanistically Predict Drug Pharmacokinetics
- Grounded in human physiology – describe time course of absorption, distribution, metabolism, and elimination of one or more drugs
- Includes anatomical or physiological parameters such as blood flow, tissue composition, enzyme abundance, drug-specific values, such as tissue-to-plasma concentration ratios, metabolism and clearance
- Make predictions on drug concentrations achieved in the absence of clinical data
- Focus to improve accuracy of predictions and incoporate PBPK models in drug development
image credit: FDA